CTL019 Out of Specification MAP for ALL or DLBCL Patients
a study on Acute Lymphoblastic Leukemia Leukemia Diffuse Large B-Cell Lymphoma Lymphoma Non-Hodgkin Lymphoma
Summary
- Eligibility
- for people ages up to 25 years (full criteria)
- Location
- at San Diego, California and other locations
- Dates
- study started
- Principal Investigator
- by Dimitrios Tzachanis
Description
Summary
Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.
Official Title
Managed Access Program (MAP) Cohort Treatment Plan CCTL019B2003I to Provide Access for Patients With Out of Specification Leukapheresis Product and/or Out of Specification Manufactured Tisagenlecleucel (CTL019; Kymriah®)
Details
The purpose of this Managed Access Program (MAP) Treatment Plan is to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release where no overwhelming safety concerns has been identified for manufacture and release of the out of specification product.
Keywords
Acute Lymphoblastic Leukemia (ALL), Diffuse Large B-cell Lymphoma (DLBCL), Acute Lymphoblastic Leukemia, ALL, Pediatric, Diffuse Large b-cell Lymphoma, DLBCL, Adult, Relapse, Refractory, CTL019, tisagenlecleucel, Kymriah, CART19, CART, CAR T cells, Chimeric antigen receptor, Manufacturing, Expanded Access, Out of Specification, B-Cell Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoid Leukemia, Lymphoma, Large B-Cell, Diffuse
Eligibility
You can join if…
Open to people ages up to 25 years
Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria:
- Patients must be treated at a healthcare facility that has been certified /qualified by Novartis to dispense and administer tisagenlecleucel in line with the tisagenlecleucel Risk Evaluation and Mitigation Strategy (REMS) in the United States (US) or the local Risk Management Plan (RMP).
- Note that tisagenlecleucel treatment should be initiated under the direction of and supervised by a HCP experienced in the treatment of hematological malignancies and trained for administration and management of patients treated with tisagenlecleucel. The healthcare facility must have tocilizumab for use in the event of cytokine release syndrome and emergency equipment per patient prior to infusion on site and ensure timely access to additional doses of tocilizumab; for detailed requirements refer to the approved local label.
- Patients must be prescribed tisagenlecleucel in line with the locally approved indications (for the precise indication statements see approved local product label). These may include:
- pediatric and young adult patients up to and (including) 25 years of age with refractory/relapsed (r/r) acute lymphoblastic leukemia (B-ALL)
- adult patients with r/r diffuse large B-cell lymphoma (DLBCL)
- Informed consent must be obtained prior to treatment
- The incoming apheresis material and/or the final manufactured product is out of specification due to failure to meet acceptance or release specifications
You CAN'T join if...
Patients eligible for this Treatment Plan must not meet any of the following criteria:
- Contraindications as per the approved local label or the IB.
Locations
- UC San Diego
not accepting new patients
San Diego California 92093-0979 United States - University of California at San Diego, Moores Cancer Ctr UCSD
not accepting new patients
San Diego California 92103 United States - Rady Children s Hospital Dept of Oncology
not accepting new patients
San Diego California 92123 United States - Rady Childrens Hospital
not accepting new patients
San Diego California 92123 United States
Lead Scientist at UCSD
Details
- Status
- not accepting new patients
- Start Date
- Sponsor
- Novartis Pharmaceuticals
- ID
- NCT03601442
- Study Type
- Expanded Access
- Last Updated